Recalls That Should Be on Your Radar—Week of February 16, 2020

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Abbot Vascular Issues Recall of Catheters Due to Potential Failure of Balloon to Deflate

Abbot Vascular has issued a recall of the NC Trek RX Coronary Dilatation Catheter and NC Traveler Coronary Dilatation Catheters with balloon diameters 4.0mm, 4.5mm, and 5.0mm. The balloons may not deflate as intended due to excessive exposure of manufacturing materials to heat during production.

Use of the devices can cause serious adverse health events, such as air embolism, thrombosis, heart attacks, and the need for additional surgery. Abbot Vascular has received 13 complaints and reports of 1 death related to the issue.

Read the recall statement.

Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Potential For Water to Enter Airway

Teleflex Medical has issued a recall of its Comfort Flo Humidification Systems products due to the risk for water to enter the circuit in the system, with potential to enter the nose and lungs of the patient.

The products are intended for use in neonatal, pediatric, and adult patients in order to provide a constant flow of heated and humidified breathing gases.

Use of the products may cause serious adverse health events, such as low oxygen in the blood. There have been 102 complaints, 8 injuries, and no deaths reported in connection with the issue.

Read the recall statement.

ResMed Recalls Stellar 100 and 150 Non-Invasive and Invasive Ventilators Due to Sound Alarm Failure

ResMed has issued a recall of Stellar 100 and 150 Ventilators which provide breathing support to patients who are non-ventilator dependent.

The recall has been issued because the sound alarm may fail to work if the device has a failed electronic part, the device is stored without AC power connected for over 36 hours, or the device powers on automatically while connected to AC power without pressing the power switch.

There has been 1 reported death associated with the products recalled.

Read the recall statement.